复方硝酸益康唑乳膏的研制及疗效和安全性评价

Preparation and efficacy as well as safety evaluation of compound econazole nitrate cream

目的制备复方硝酸益康唑乳膏,对质量控制方法进行研究,并进行临床研究。方法通过选择不同的乳化剂,进行处方筛选。采用高效液相色谱法测定含量。并对135例皮肤真菌病患者,采用多中心随机对照平行双盲法进行临床研究。结果通过选择不同的乳化剂,确定了最佳处方。建立了测定复方硝酸益康唑乳膏含量的方法,硝酸益康唑和醋酸曲安奈德的平均回收率分别为99.56%和99.49%(n=9),线性关系良好。复方硝酸益康唑乳膏对体股癣及花斑癣的治愈率为53.49%,有效率为90.70%,真菌转阴率为96.97%;对手足癣的治愈率为57.69%,有效率为96.15%,真菌转阴率为100%。结论处方设计合理。测定方法灵敏度高,专属性好,适用于复方硝酸益康唑乳膏的含量测定。临床疗效及安全性与对照药曲安奈德益康唑乳膏(商品名:派瑞松)相似。

Purpose In compound econazole nitrate cream preparation, quality control method was studied and the conduction of clinical research was finished. Methods Through selections of different kinds of emulsifiers, formulations were screened. The HPLC method was used to determine the contents. In 135 cases of fungal skin disease patients,a multi center randomized controlled parallel double blind clini- cal pratice was conducted. Results By choosing different emulsifiers, the best formulation was deter- mined. HPLC method was established to determine the content of compound eeonazole nitrate cream. The average recovery of econazole nitrate and triamcinclone acetonide acetate was 99.56% , and 99.49% （ n = 9）. The linear relationship was well matched. Compound eeonazole nitrate cream on tinea corporis and tin- ea versicolor tinea of the curerate was 53.49% ,effective rate was 90.70% , and the fungus negative rate was 96.97%. Of tinea pedis,the cure rate was 57.69% ,the effective rate was 96.15% ,and the fungus negative rates was 100%. Conclusion The design of this fomulation is reasonable. The method is sensitive and specific,which can be used for determination of the content in compound econazole nitrate cream. It is similar in clinical efficacy and safety to triamcinolone acetonide econazole ointment（trade name：Pevi- sone） , a controlled drug.